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REMS: Requirements, Regulation, and Enforcement — Evolution from Safety Program to Enforcement Tool
REMS has evolved into a powerful enforcement tool.
Last year there were to significant settlements involving a manufacturer’s failure to comply with REMS strategies.
The Novo Nordisk settlement resulted in disgorgement of $12 million and a payment of $46.5 mill to resolve the False Claims Act liability.
The settlement by Aegerion contained both criminal and civil components. On the criminal side, the company admitted two misdemeanor violations of the FD&C Act, and agreed to pay $7.2 million in criminal fines and forfeiture. The company also entered into a Deferred Prosecution Agreement with the government to resolve charges of conspiracy to violate HIPAA. The civil settlement included a $28.8 million payment for False Claims Act violations, a Corporate Integrity Agreement, and a Consent Decree of permanent injunction.
FDAnews has called on Anne K. Walsh, a Washington, D.C., attorney to discuss why the REMS evolution has occurred and how to prepare for future changes. Her presentation alerts you to likely regulatory and legislative changes ahead in coming months, and positions you for better compliance. You’ll learn about:
Failure to prepare for REMS changes could result in penalties — civil, and even criminal ones. Don’t take that risk.
Anne K. Walsh, Director, Hyman, Phelps & McNamara, P.C., Washington, DC
Anne K. Walsh counsels clients on compliance and enforcement issues, including FDA inspections, seizure and injunction actions, warning letters, and recalls. She focuses on defending companies against allegations of fraud related to marketing and promotion, cGMP and QSR, health care, and clinical studies, with particular emphasis on cases involving joint criminal and civil investigations under the FDCA and the False Claims Act (FCA). She also has successfully sued the government for violating the Administrative Procedure Act (APA). She applies her enforcement expertise to aid companies in compliance efforts, via internal investigations or risk assessment audits.
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